Cleared Traditional

PREGNACOL PREGNANCY TEST

K972606 · Immunostics Inc., · Chemistry
Aug 1997
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K972606 is an FDA 510(k) clearance for the PREGNACOL PREGNANCY TEST, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on August 29, 1997, 49 days after receiving the submission on July 11, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K972606 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1997
Decision Date August 29, 1997
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHJ — Agglutination Method, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155